MetabolismNCT01733563
Sugar Sweetened Beverages (SSB)- Effects on Metabolism
A study testing Soft drink consumption in people with Metabolism, run by University of Zurich at 1 site in Switzerland.
Trial summary
The objective of this study is to investigate the impact of sugar sweetened beverages on the fat metabolism of healthy young men. It is well known that consumption of beverages sweetened with fructose is associated with different health risks such as type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men only
- Conditions the study is for
- Metabolism
- What is being tested?
- Soft drink consumption
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2013to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Healthy male volunteers aged 18-30
- BMI between 19-24 kg/m2
- Non-smoker
Who cannot join
- Acute or chronic infections, malignant disease, renal, hepatic (more than two-fold increased transaminases), pulmonary, neurological (epilepsy) or psychiatric diseases, manifested atherosclerosis, or any other disease precluding participation in the study.
- Diabetes
- Known alcohol, substance or drug abuse, concomitant medication
- More than three hours of physical exercise per week
- Consumption of more than 2 times 3 dl SSB daily
- Subjects likely to fail to comply with the study protocol
- Subjects who do not give informed consent
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Endocrinology and Diabetology
Zurich, Canton of Zurich, 8091
About this study
Official title: Effects of Carbohydrate Containing Diets on Lipid Metabolism & Fatty Acid Oxidation in Healthy Young Men - a Randomized, Double-Blinded Study.
The objective of this study is to investigate the impact of sugar sweetened beverages on the fat metabolism of healthy young men. It is well known that consumption of beverages sweetened with fructose is associated with different health risks such as type 2 diabetes. The present study has been designed to dissect differences in the metabolic pathways of fructose and glucose, but also metabolic adaptations during fructose, glucose and sucrose diets. During a period of seven weeks subjects will consume either fructose, glucose or sucrose sweetened beverages or continue their usual drinking habits. During these seven weeks there will be different metabolic investigations using stable isotope tracers. First, the rate of lipolysis and beta-oxidation will be determined. Second, the rates of fatty acid synthesis will be measured. During all examinations there will also be substrate- and energy-utilization measurements by indirect calorimetry, blood analysis and morphometric measurements. Based on the literature main hypotheses are: Fructose enhances de novo lipogenesis postprandially and also in the fasting state significantly more than glucose by enhanced expression of lipogenic enzymes. Fructose decreases beta oxidation via downregulation of oxidative enzymes.
- Conditions
- Metabolism
- Being tested
- Soft drink consumption
- Keywords
- sugar sweetened beverages, fructose, lipogenesis, beta-oxidation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soft drink consumptionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| fructose sweetened beverage | Experimental | Soft drink consumption:
Subjects have to drink a fructose sweetened beverage (3x 200ml per day, 13.3g fructose/100ml) during 7 weeks Receives: Procedure: Soft drink consumption |
| glucose sweetened beverage | Experimental | Soft drink consumption:
Subjects have to drink a glucose sweetened beverage (3x 200ml per day, 13.3g glucose/100ml) during 7 weeks Receives: Procedure: Soft drink consumption |
| sucrose sweetened beverage | Experimental | Soft drink consumption:
Subjects have to drink a sucrose sweetened beverage (3x 200ml per day, 13.3g sucrose/100ml) during 7 weeks Receives: Procedure: Soft drink consumption |
| No change of eating habits | Experimental | No Soft drink consumption (no soft drink diet):
Subjects do not change their eating habits during 7 weeks Receives: Procedure: Soft drink consumption |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipogenesis
Measurement of lipogenesis is based on i. v. administration of stable isotope labelled acetate (1,2-13C-acetate). 13C incorporation into palmitate is quantified by mass-spectrometry. 13C incorporation correlates to the rate of fatty acid synthesis.
Measured: After total 6 weeks dietary intervention
Secondary outcomes (1)
Lipolysis
Measurements using stable isotopes
Measured: After total 6 weeks dietary intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2012 (estimated)
- Study startApr 2013
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MetabolismStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation, University of Lausanne
- Responsible party
- Sponsor
- Investigators
- Philipp Gerber, MD, Principal investigator, University Hospital Zurich, Endocrinology and Diabetology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01733563
- Sponsor's protocol ID
- SSB-Effects on metabolism
- Status last verified
- May 2016
- First submitted
- 9 Nov 2012
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Geidl-Flueck B, Hochuli M, Nemeth A, Eberl A, Derron N, Kofeler HC, Tappy L, Berneis K, Spinas GA, Gerber PA. Fructose- and sucrose- but not glucose-sweetened beverages promote hepatic de novo lipogenesis: A randomized controlled trial. J Hepatol. 2021 Jul;75(1):46-54. doi: 10.1016/j.jhep.2021.02.027. Epub 2021 Mar 6.
PubMed 33684506
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Carbohydrate Containing Diets on Lipid Metabolism & Fatty Acid Oxidation in Healthy Young Men - a Randomized, Double-Blinded Study.
- ClinicalTrials.gov ID
- NCT01733563
- Acronym / sponsor ID
- SSB-Effects on metabolism
- Conditions
- Metabolism
- Keywords
- sugar sweetened beverages, fructose, lipogenesis, beta-oxidation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation, University of Lausanne
- Study start
- Apr 2013
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 27 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to investigate the impact of sugar sweetened beverages on the fat metabolism of healthy young men. It is well known that consumption of beverages sweetened with fructose is associated with different health risks such as type 2 diabetes. The present study has been designed to dissect differences in the metabolic pathways of fructose and glucose, but also metabolic adaptations during fructose, glucose and sucrose diets. During a period of seven weeks subjects will consume either fructose, glucose or sucrose sweetened beverages or continue their usual drinking habits. During these seven weeks there will be different metabolic investigations using stable isotope tracers. First, the rate of lipolysis and beta-oxidation will be determined. Second, the rates of fatty acid synthesis will be measured. During all examinations there will also be substrate- and energy-utilization measurements by indirect calorimetry, blood analysis and morphometric measurements. Based on the literature main hypotheses are: Fructose enhances de novo lipogenesis postprandially and also in the fasting state significantly more than glucose by enhanced expression of lipogenic enzymes. Fructose decreases beta oxidation via downregulation of oxidative enzymes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| fructose sweetened beverage | Experimental | Procedure: Soft drink consumptionSoft drink consumption: Subjects have to drink a fructose sweetened beverage (3x 200ml per day, 13.3g fructose/100ml) during 7 weeks |
| glucose sweetened beverage | Experimental | Procedure: Soft drink consumptionSoft drink consumption: Subjects have to drink a glucose sweetened beverage (3x 200ml per day, 13.3g glucose/100ml) during 7 weeks |
| sucrose sweetened beverage | Experimental | Procedure: Soft drink consumptionSoft drink consumption: Subjects have to drink a sucrose sweetened beverage (3x 200ml per day, 13.3g sucrose/100ml) during 7 weeks |
| No change of eating habits | Experimental | Procedure: Soft drink consumptionNo Soft drink consumption (no soft drink diet): Subjects do not change their eating habits during 7 weeks |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male volunteers aged 18-30
- BMI between 19-24 kg/m2
- Non-smoker
Key exclusion criteria (7 listed)
- Acute or chronic infections, malignant disease, renal, hepatic (more than two-fold increased transaminases), pulmonary, neurological (epilepsy) or psychiatric diseases, manifested atherosclerosis, or any other disease precluding participation in the study.
- Diabetes
- Known alcohol, substance or drug abuse, concomitant medication
- More than three hours of physical exercise per week
- Consumption of more than 2 times 3 dl SSB daily
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Soft drink consumption | Procedure or surgery | No change of eating habits, fructose sweetened beverage, glucose sweetened beverage, sucrose sweetened beverage |
Primary outcome
Lipogenesis
Time frame: After total 6 weeks dietary intervention
Measurement of lipogenesis is based on i. v. administration of stable isotope labelled acetate (1,2-13C-acetate). 13C incorporation into palmitate is quantified by mass-spectrometry. 13C incorporation correlates to the rate of fatty acid synthesis.
1 secondary outcome
Lipolysis
Time frame: After total 6 weeks dietary intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2016.
- Derived from this study: PubMed 33684506Geidl-Flueck B, Hochuli M, Nemeth A, Eberl A, Derron N, Kofeler HC, Tappy L, Berneis K, Spinas GA, Gerber PA. Fructose- and sucrose- but not glucose-sweetened beverages promote hepatic de novo lipogenesis: A randomized controlled trial. J Hepatol. 2021 Jul;75(1):46-54. doi: 10.1016/j.jhep.2021.02.027. Epub 2021 Mar 6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philipp Gerber, MD principal investigator
University Hospital Zurich, Endocrinology and Diabetology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soft drink consumption in people with Metabolism, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lipogenesis (time frame: After total 6 weeks dietary intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01733563, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2016.